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For immediate release: April 16th 2007. Gerraspine AG today announced that the Company was awarded CE certification for its FENIX™ Facet implant.
Mr. Horace Hale, c.e.o. and major shareholder of Gerraspine AG stated; "This represents a major milestone achievement in our quest to bring to the field of spine surgery a device that will restore function with a resultant long term effect. We are confident that our technology, the FENIX™ Facet implant will be the preferred option for a long term solution to the problem of providing ¨Normal¨, pain free motion to the human Functional Spine Unit". Even though the CE Mark allows the company to freely market the device in any European Union member country, the company intends to complete a rigorous scientific program before initiating a full European market launch. In addition, Gerraspine AG has initiated the process to obtain IDE approval to begin U.S. clinical trials by the end of Q4 2007. Our implant has been developed to provide a motion preserving alternative to spinal fusion, to patients suffering from chronic low back pain. The system resurfaces diseased facet anatomy, thereby, allowing the surgeon to alleviate pain while restoring physiological motion and stability to the lumbar spine. Our implant is suitable for use as a stand alone implant or with any artificial disc or disc nucleus replacement implant. Gerraspine AG is a Swiss registered Corporation dedicated to providing the specialist spine surgeon with the means to restore normal mobility and pain free function to the spine, with a resultant long term effect. -Download CE Certificate (PDF) |